ReBec (Registro Brasileiro de Ensaios Clinicos)
Brazilian Clinical Trials Registry
Av. Brasil, 4.365 - Pavilhão Haity Moussatché
sala 214 Manguinhos, Rio de Janeiro
Tel.: (55xx21) 3865-3258 Fax: (55xx21) 2270-2668
- Registry URL: http://www.ensaiosclinicos.gov.br
- Registration URL: http://www.ensaiosclinicos.gov.br
- 1. Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- 2. Is the Registry open to all prospective registrants (ICMJE), either internationally, or within one or more specific countries?
- 2.1. From which countries will the Registry accept trials for registration?
For all countries
- 2.2. If the Registry is not open to ALL registrants (that is, accepts trials only from a particular sponsor, health care condition (eg cancer), intervention, etc) please specify which trials the Registry is open to.
- 3. Is the Registry able to collect and publicly display the WHO Trial Registration Data Set? (ICMJE)
- 4. Does the Registry endeavour to keep registered information up-to-date?
- 4.1. Does the Registry have a reminder system to facilitate the submission of updated information by the responsible registrant?
- 4.2. Does the Registry highlight or flag records that are not current (have not been updated in more than 12 months) so readers are aware that information contained in such records may not be current?
- 5. Does the Registry ever remove a trial once it has been registered?
Quality and Validity
- 6. Does the Registry have a mechanism in place to ensure the validity of the registered data? (ICMJE)
- 6.1. Does the registry contact Responsible Registrants when one or more items in the Trial Registration Data Set are incomplete or potentially inaccurate?
- 6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
- 6.2.1 If the answer to 6.1 is "no", then please describe your plan for completing your SOPs and the date by which you expect them to be complete
- 6.2.2 If the answer to 6.1 is "yes" then please let us know the languages in which the SOPs are written:?
- 6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
- 6.4. Please briefly describe these compliance mechanisms.
The SOPs will be implemented based on an order of priority – first those related to the registration and review process, then those concerned to security/storage and import/export of the data. Training of RBEC staff members and officials from the IT department will be delivered regularly to guarantee the adoption of the SOPs.
- 7. Does the registry maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked?
- 7.1. If yes, then please describe how users can access the audit trail
Every register, after modifications, will create a new register with the updated information, This new register have a link to the old copy of the register and the user can track the modifications in the study since its first registration. This new register will have the same number, but with updated fields and a link to the old register (with outdated fields). It´s in accordance to the logic of the ICTRP primary registries.
- 8. Does the Registry agree to participate in the development of International Standards for Clinical Trial Registries?
- 9. Is the WHO Trial Registration Data Set accessible to the public at no charge? (ICMJE)
- 10. Is the WHO Trial Registration Data Set electronically searchable? (ICMJE)
- 11. Is the WHO Trial Registration Data Set available in English?
- 12. Can registrants submit a trial for registration at any time of day on any day of the week (24 hours a day, seven days a week)?
- 13. Can the register be searched at any time of day on any day of the week (24 hours a day, seven days a week)?
- 14. It is desirable that the WHO Trial Registration Data Set be available in the language/s of the countries served by the registry. Please indicate the languages in which the registered information is displayed.
English and Portuguese
Multicentre trials that are recruiting participants in both Portuguese and Spanish speaking countries may choose to also register their trials on the REBEC registry in Spanish (in addition to Portuguese and English)
- 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
- 15. What quality control measures does the registry have in place to make sure that all items in the WHO Trial Registration Data Set are as complete and accurate as possible?
At the application stage, it is compulsory for trial applicants to provide all 20 data items TRDS. After submission of a trial registration request, the BCTR performs single and cross checks manually and automatically to assess the plausibility and the completeness of data against the standards required for the 20 items TRDS. Missing, inconsistent or obviously inaccurate data are queried with the Registrant via email. Registrants are required to make the required changes themselves online and re-submit the trial. Once the trial submission fulfils the 20 item TRDS requirements, the trial is registered by the BCTR staff, after which a registration number and date are automatically generated and the trial is publicly displayed on the BCTR website.
- 16. Does the Registry have processes in place to prevent the registration of a single trial more than once on their register?
- 16.1. Please briefly describe these processes.
Before registering, the registrant is informed that the study must be registered once and it is offered a link to search for his study in the registry database. After submission, administrators check the WHO Portal. In case of an international multicenter study the original unique identification number is registered as an secondary ID.
- 17. Does the Registry agree to facilitate the retrospective linking (or bridging) on the WHO Search Portal of a single trial registered with more than one registry by encouraging Responsible Registrants to enter secondary identifiers, including the UTN?
- 18. Does the Registry agree, as part of the registration process, to search the WHO Search Portal to ascertain if the trial has already been registered on another WHO Primary Registry?
- 19. Does the Registry agree to submit the WHO Trial Registration Data Set for all records on their registry to the Central Repository?
- 19.1. Has a sample data set been submitted?
- 20. Does the Registry have access to a database that is used to store and manage the submitted data?
- 20.1. If no, please provide details of the database that will be used and where it is based.
- 21. Does the Registry have access to adequate information technology support?
- 22. Does the Registry have adequate security and other provisions against data corruption/loss?
Administration and Governance
- 23. Does the Registry have at least a national remit?
- 23.1. From which countries does the Registry have the remit to act as their Primary Registry?
- 24. Does the Registry have a letter of support from the relevant Ministry of Health or other agency?
- 24.1. Please specify the names of the government agencies that have given their support.
The BCTR is funded by the brazilian Ministry of Health through its Secretaria de Ciência, Tecnologia e Insumos Estratégicos (SCTIE).
- 25. Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- 25.1. Please indicate the web address where this information is displayed.
- 26. Is the Registry managed by a not-for-profit agency? (ICMJE)
- 27. Should the register cease to function, does the register agree that at least the WHO Trial Registration Data Set for all trial records will be transferred to a WHO Primary Register?
- 27.1. Does the registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a WHO Primary Registry?
- 28. It is desirable that Primary Registries have a strategy in place addressing the medium to long term sustainability of the registry. Does the Registry have such a strategy in place?
- 29. Other Governance information:
- 29.1. What is the name of the agency (or agencies) that fund the registry?
Fundo Nacional de Saúde
Fundação Oswaldo Cruz
- 29.2. What is the name of the agency that manages the registry?
Fundação Oswaldo Cruz
- 29.3. Is the agency that manages the registry a for-profit agency?
- 29.4. If the agency is for-profit, is the data on the register (database) also available on a Registry that is managed by a not-for-profit agency?
- 29.5. If the answer to 29.4 is "yes", then please specify the name of the additional Registry.
- 29.6. Please describe any other ownership or governance issues of relevance to the register. (eg Does the register have an Advisory Board. If so, what is its role?
There is an Advisory Board that is responsible for definition of the norms of governance and a Executive Committee that reviews the procedures of operation of the registry.